In China, PL-5 has completed its Phase III clinical trials, and received NDA approval from the NMPA in June 2026. We currently expect commercial launch in 2026.
Business · 第 161 页
In 2024 and 2025, and the six months ended June 30, 2025 and 2026, our R&D expenses amounted to RMB80.7 million, RMB57.2 million, RMB25.7 million and RMB24.4 million.
Financial Information · 第 223 页
Although we currently have no drugs realized commercial sale and have not generated any revenue from drug sales, we expect to commercialize one or more of our drug candidates over the coming years.
As of the Latest Practicable Date, we had self-developed a pipeline comprised of seven small-molecule drug candidates, with a therapeutic focus on hematologic malignancies and autoimmune diseases.
Business · 第 147 页
In August 2024, we submitted our first NDA to the CDE for the treatment of MF, and received NDA approval in April 2026.
Business · 第 139 页
We have not generated any revenue from the product sales since inception.
Incorporated in 2019, we are a clinical-stage gene therapy company dedicated to the in-house development of recombinant adeno-associated virus (“rAAV”) gene therapies.
Summary · 第 1 页
As of the Latest Practicable Date, our product pipeline consisted of six in-house developed rAAV gene therapy candidates, including (i) two Core Products, namely FT-002, a drug candidate being investigated to treat X-linked retinitis pigmentosa (“XLRP”), and FT-003, a drug candidate being investigated to treat neovascular age-related macular degeneration (“nAMD”) and diabetic macular edema (“DME”) through intravitreal injections;
Summary · 第 1 页
As of the Latest Practicable Date, we had not obtained marketing approval for any drug candidates, nor had we generated any revenue from product sales.
As of the Latest Practicable Date, we had developed a pipeline of five clinical-stage product candidates, including two Core Products, namely VVN461(HD) and VVN001, and three other product candidates.
Business · 第 171 页
We commenced a Phase III clinical trial in patients with moderate-to-severe DED in China in June 2024 and expect to complete such trial in the first half of 2027.
Business · 第 187 页
Our business and results of operations depend on our ability to successfully develop and manufacture as well as our receipt of regulatory approval for and successful commercialization of our product candidates.
杭州糖吉医疗科技股份有限公司HANGZHOU TANGJI MEDICAL TECHNOLOGY CO., LTD.
核心产品GBS已商业化另有13项管线产品
As of the Latest Practicable Date, we had (i) one Core Product, the Gastric Bypass Stent system (GBS), which is a digestive endoscopic duodenal-jejunal bypass liner (DJBL) device indicated for obesity, and we are expanding the approved indications of the GBS for a lower BMI; (ii) two other products and one digital health management platform that we had obtained registration approval; and (iii) 13 other pipeline products.
Summary · 第 1 页
During the Track Record Period, we incurred research and development expenses of RMB41.1 million, RMB48.7 million, RMB22.0 million and RMB38.7 million in the year ended December 31, 2024 and 2025 and the six months ended June 30, 2025 and 2026, respectively.
Financial Information · 第 237 页
Our long-term growth is dependent on the successful development of our pipeline candidates, especially our Key Products, the GBS-SH, the GBS-DM, the DIGB and RIGB.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET EXG102-031 SUCCESSFULLY.
Business · 第 161 页
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET EXG001-307 SUCCESSFULLY.
Business · 第 171 页
During the Track Record Period, we incurred research and development expenses of RMB145.0 million, RMB103.9 million, RMB57.4 million and RMB53.4 million for the years ended December 31, 2024 and 2025 and the six months ended June 30, 2025 and 2026, respectively, in each case representing the largest component of our cost structure during the relevant period.
As of the Latest Practicable Date, we had five approved products and five product candidates under development.
Business · 第 134 页
iNOwill is positioned primarily for ICU and hospital bedside use, and has been registered as a Class III medical device in China for PH since 2022 and certified as a Class IIb medical device for PH under the EU MDR since 2025.
Business · 第 134 页
In 2024, 2025 and for the six months ended June 30, 2025 and 2026, our R&D expenses amounted to RMB33.0 million, RMB34.7 million, RMB13.7 million and RMB20.3 million, respectively, accounting for 36.5%, 38.5%, 36.1% and 34.9% of the total operating expenses, respectively, and 72.4%, 54.9%, 61.3% and 34.8% of our total revenue during the same years/periods, respectively.
征祥医药（南京）集团股份有限公司Zenshine Pharmaceuticals (Nanjing) Group Co., Ltd.
商业化阶段18A生物科技公司
We have one Core Product, sebaloxavir marboxil tablets, which is an inhibitor targeting the influenza virus polymerase acidic protein (“PA”) endonuclease.
Summary · 第 1 页
As of the Latest Practicable Date, we have developed a pipeline of six proprietary small molecule drug assets, including our commercialized anti-viral sebaloxavir marboxil tablets, a late clinical stage sebaloxavir marboxil for suspension (in the form of granules-for-suspension) targeting pediatric influenza patients, pyrophosphatase/phosphodiesterase 1 (“ENPP1”) inhibitor ZX-8177 for the treatment of solid tumors, with an IND application submitted to the NMPA in August 2026, subsequent to the Latest Practicable Date, for the treatment of hypophosphatasia (“HPP”), and an IND-enabling stage DNA polymerase inhibitor ZX-12042B for the treatment of human papillomavirus (“HPV”) infections.
Summary · 第 1 页
we have sufficient working capital to cover at least 125% of our costs, including research and development costs, selling expenses and administrative and other operating expenses for at least the next 12 months from the date of this document.
Our Core Product, TSN1611, is an orally bioavailable KRAS G12D inhibitor, which is currently under phase 2 clinical trials in both the United States and China and is advancing toward a next-phase clinical trial as monotherapy for the treatment of NSCLC.
Financial Information · 第 239 页
As of the Latest Practicable Date, we had not obtained marketing approval for any drug candidates, nor had we generated any revenue from product sales.
Business · 第 199 页
Although we currently have no product approved for commercial sale and have not generated any revenue from product sales, we expect to commercialize one or more of our drug candidates over the coming years as they progress through late-stage development.
We have eight product candidates, including two self-developed Core Products D-2570 and taragarestrant (D-0502).
Summary · 第 1 页
our Core Products tyrosine kinase 2 ("TYK2") inhibitor D-2570 and oral estrogen receptor degrader ("SERD") taragarestrant (D-0502) are both advancing through Phase III registration trials
As of the Latest Practicable Date, we have established a pipeline consisting of nine CAR-T product candidates for the treatment of solid tumors, hematological malignancies and auto-immune diseases, of which four were in clinical development stage.
Financial Information · 第 243 页
As of the Latest Practicable Date, we had launched a registrational Phase III trial in China with IMC002 as a treatment for advanced gastric cancer patients who have received at least two prior lines of systemic treatment.
Financial Information · 第 243 页
We currently expect to complete this registrational clinical trial and submit an NDA application to the NMPA in 2027 with respect to IMC002 as a third-line treatment for gastric cancer/GEJ adenocarcinoma.
Incepted in May 2014, we are a biopharmaceutical company with a pipeline of proprietarily-developed innovative drug candidates centred around the RAS signalling pathways and synthetic lethality mechanism, including (i) one Core Product GH21, an allosteric SHP2 inhibitor, the monotherapy of which is indicated for solid tumour, and the combination therapies of which are indicated for KRAS^G12C^ mutated solid tumours, 3^rd^-generation EGFR-TKI resistant NSCLC, and MAPK-pathway activated solid tumours respectively; and (ii) seven other drug candidates.
Summary · 第 1 页
All of our drug candidates are innovative drugs which are classified as Category I under the Administrative measures for Drug Registration, and are self-developed by us.
Summary · 第 4 页
While we currently have no drugs approved for commercial sales and have not generated any revenue from drug sales, we expect to commercialise one or more of our drug candidates over the coming years as they move towards the final stages of development and if they receive the requisite regulatory approvals.
We primarily engage in the research, development and commercialization of proprietary drugs in the immune-inflammation field.
Business · 第 151 页
As of the Latest Practicable Date, our product pipeline comprised four proprietary drug candidates covering 10 indications, as well as five generic drug candidates targeting multiple chronic inflammatory diseases, all of which are self-developed.
Business · 第 151 页
Our other net income increased significantly from RMB11.2 million in 2024 to RMB36.3 million in 2025, primarily attributable to the RMB30.0 million government grants we received in 2025 as our Pumecitinib gel for atopic dermatitis entered Phase III clinical trials.
Founded in 2007, we are a clinical-stage pharmaceutical company.
Summary · 第 1 页
Our R&D expenses incurred for our two Core Products were approximately RMB11.9 million, RMB26.3 million, RMB5.3 million and RMB14.8 million for the years ended December 31, 2024 and 2025 and the five months ended May 31, 2025 and 2026, respectively, accounting for 72.5%, 69.0%, 51.0% and 77.9% of our total research and development expenses, and 30.7%, 29.9%, 24.2% and 39.5% of our total operating expenses (i.e. selling and distribution expenses, administrative expenses, research and development expenses) during the same periods, respectively.
Business · 第 184 页
None of our Core Products or key product has been approved or in commercial stage, including DHMP, a dissolving microneedle patch for pediatric preoperative sedation, advanced to a Phase II clinical trial, and XJN010, a clinical-stage nasal inhalation drug formulation developed for the on-demand treatment of “Off” episodes in patients with Parkinson’s disease who are already receiving a dopa decarboxylase inhibitor/levodopa regimen.
Our self-discovered Core Product MVR-T3011 is a novel, Phase II herpes simplex virus type 1 (HSV-1)-based oncolytic immunotherapy candidate that pairs potent tumor lysis with expression of both anti-PD-1 antibody and IL-12.
Summary · 第 1 页
We initiated a Phase II clinical trial of MVR-T3011 administered intravesically for the treatment of high-risk BCG-unresponsive NMIBC papillary and carcinoma in situ (CIS) cohorts in the U.S., with the first patient dosed in June 2025.
Business · 第 122 页
In 2023, 2024, 2025 and five months ended May 31, 2025 and 2026, our research and development expenses amounted to RMB136.2 million, RMB111.5 million, RMB112.0 million, RMB26.4 million and RMB31.0 million, respectively.
As of the Latest Practicable Date, we were developing a total of eight drug candidates, three of which were in advanced stages, including one candidate that had received NDA approval and was set for commercialization, one candidate for which an NDA had been submitted, and one candidate undergoing Phase 3 clinical trials.
Business · 第 164 页
our pipeline for assisted reproductive treatments includes (i) JZB30 (Core Product), a rhFSH candidate in lyophilized form, for which we received NDA approval in April 2025, currently being evaluated for the indication expansion for oligospermia
Business · 第 165 页
With respect to JZB05, it is undergoing Phase 3 clinical trials at over 40 centers across mainland China.
According to the CIC Report, it is currently the only vaccine candidate targeting Staphylococcus aureus globally that is undergoing a Phase III clinical trial.
Business · 第 139 页
As of Latest Practicable Date, we have completed the enrollment of all 6,014 subjects for the Phase III clinical trial.
Business · 第 142 页
Delays in clinical trial timelines, unfavorable clinical data, or a failure to obtain NDA approval for rFSAV or our other vaccine candidates, such as our rHPV, which has received approval for a Phase I clinical trial in Australia, would significantly delay or prevent the generation of revenue from these products, which could adversely affect our business, results of operations, financial condition and prospects.
As of the Latest Practicable Date, we had commercialized four vaccine products covering two disease areas in the PRC, namely rabies and influenza.
Business · 第 140 页
Out of these four vaccine candidates that have received clinical trial approval or are in clinical stages, we expect to launch at least two from 2026 to 2028.
Business · 第 140 页
Our R&D expenses increased during the Track Record Period, amounting to RMB53.3 million, RMB81.0 million and RMB121.7 million in 2023, 2024 and 2025, representing 16.4%, 99.6% and 23.1% of total revenue, respectively.
Our pipeline comprises four clinical-stage drug candidates, including our Core Product EMB-01 (targeting EGFR/cMET) and three TCE-based assets EMB-06 (targeting BCMA/CD3), EMB-07 (targeting ROR1/CD3) and EMB-15 (targeting ALPP(G)/CD3), and four preclinical drug candidates, EM1033 (targeting CD228/CD3), EM1034 (targeting LY6G6D/CD3), EM1039 and EM1042.
Business · 第 172 页
Our business and results of operations depend on our ability to continuously advance preclinical and clinical development of, and obtain the requisite regulatory approvals for, our drug candidates.
Financial Information · 第 235 页
As of December 31, 2025, our cash and cash equivalents amounted to RMB289.7 million.